GER Poses a Potential Risk for Late Complications of BPD
2020年3月25日 更新者:Shucheng Zhang、Shengjing Hospital
Gastroesophageal Reflux Poses a Potential Risk for Late Complications of BPD: A Prospective Study
Bronchopulmonary dysplasia (BPD) is a common condition in the low birth weight infants.
Although most of the BPD symptoms improved after a regular treatment in infancy, there are still a few late complications left such as the frequent respiratory symptoms, a slower weight gain and even sudden death.
These late complications have made so much trouble to the healthcare of BPD infants.
How to find the risk factors and to reduce the prevalence of these late symptoms becomes necessary.
In this study, a cohort of BPD infants was observed with the late complications obtained by a monthly followed up for 18 months after discharge, the prevalence and risk factors of the late complications of BPD were analyzed by logistic regression.
As one of the risk factors, GER was verified whether to play a critical role in these late complications.
研究概览
地位
地位
完全的
研究类型
研究类型
观察性的
注册 (实际的)
注册
187
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Liaoning
-
Shenyang、Liaoning、中国、110004
- Shengjing Hospital
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
资格标准
适合学习的年龄
不超过 7个月 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Extremely Premature Infants with Bronchopulmonary Dysplasia
描述
Inclusion Criteria:
- the extremely premature infants with bronchopulmonary dysplasia
Exclusion Criteria:
- other congenital malformations such as gastrointestinal and or neurogenic disease
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
the Late Complications of BPD Infants
大体时间:18 months
|
In all patients, complications were evaluated via questionnaires at 3, 6, 9 and 12 months corrected for premature age, including respiratory symptoms (including home respiratory support, respiratory medication administration, cough without cold at least once per week, re-hospitalization due to respiratory diseases), vomiting when feeding, hypoxic ischemic injury, retinopathy of prematurity, rehospitalization and sudden death.
|
18 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.
- Kalikkot Thekkeveedu R, Guaman MC, Shivanna B. Bronchopulmonary dysplasia: A review of pathogenesis and pathophysiology. Respir Med. 2017 Nov;132:170-177. doi: 10.1016/j.rmed.2017.10.014. Epub 2017 Oct 24.
- Bonadies L, Zaramella P, Porzionato A, Muraca M, Baraldi E. Bronchopulmonary dysplasia: what's new on the horizon? Lancet Child Adolesc Health. 2018 Aug;2(8):549-551. doi: 10.1016/S2352-4642(18)30181-0. Epub 2018 Jun 27. No abstract available.
- Papagianis PC, Pillow JJ, Moss TJ. Bronchopulmonary dysplasia: Pathophysiology and potential anti-inflammatory therapies. Paediatr Respir Rev. 2019 Apr;30:34-41. doi: 10.1016/j.prrv.2018.07.007. Epub 2018 Jul 29.
- Perez Tarazona S, Solano Galan P, Bartoll Alguacil E, Alfonso Diego J. Bronchopulmonary dysplasia as a risk factor for asthma in school children and adolescents: A systematic review. Allergol Immunopathol (Madr). 2018 Jan-Feb;46(1):87-98. doi: 10.1016/j.aller.2017.02.004. Epub 2017 Jun 28.
- Clyman RI. Patent ductus arteriosus, its treatments, and the risks of pulmonary morbidity. Semin Perinatol. 2018 Jun;42(4):235-242. doi: 10.1053/j.semperi.2018.05.006. Epub 2018 May 10.
- Nagiub M, Kanaan U, Simon D, Guglani L. Risk Factors for Development of Pulmonary Hypertension in Infants with Bronchopulmonary Dysplasia: Systematic Review and Meta-Analysis. Paediatr Respir Rev. 2017 Jun;23:27-32. doi: 10.1016/j.prrv.2016.11.003. Epub 2016 Nov 22.
- Vandenplas Y, Goyvaerts H, Helven R, Sacre L. Gastroesophageal reflux, as measured by 24-hour pH monitoring, in 509 healthy infants screened for risk of sudden infant death syndrome. Pediatrics. 1991 Oct;88(4):834-40.
- Hassall E. Decisions in diagnosing and managing chronic gastroesophageal reflux disease in children. J Pediatr. 2005 Mar;146(3 Suppl):S3-12. doi: 10.1016/j.jpeds.2004.11.034.
- Rosen R, Vandenplas Y, Singendonk M, Cabana M, DiLorenzo C, Gottrand F, Gupta S, Langendam M, Staiano A, Thapar N, Tipnis N, Tabbers M. Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2018 Mar;66(3):516-554. doi: 10.1097/MPG.0000000000001889.
- Cohen S, Bueno de Mesquita M, Mimouni FB. Adverse effects reported in the use of gastroesophageal reflux disease treatments in children: a 10 years literature review. Br J Clin Pharmacol. 2015 Aug;80(2):200-8. doi: 10.1111/bcp.12619. Epub 2015 Jun 11.
- Shakir AK, Altaf MA. Azithromycin Induces Migrating Motor Complexes in Pediatric Patients Undergoing Antroduodenal Motility Studies. J Pediatr Pharmacol Ther. 2018 Sep-Oct;23(5):390-394. doi: 10.5863/1551-6776-23.5.390.
- Parad RB, Davis JM, Lo J, Thomas M, Marlow N, Calvert S, Peacock JL, Greenough A. Prediction of respiratory outcome in extremely low gestational age infants. Neonatology. 2015;107(4):241-8. doi: 10.1159/000369878. Epub 2015 Mar 3.
- Wang LJ, Hu Y, Wang W, Zhang CY, Bai YZ, Zhang SC. Gastroesophageal Reflux Poses a Potential Risk for Late Complications of Bronchopulmonary Dysplasia: A Prospective Cohort Study. Chest. 2020 Oct;158(4):1596-1605. doi: 10.1016/j.chest.2020.05.523. Epub 2020 May 22.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
学习开始
2017年1月9日
初级完成 (实际的)
初级完成
2018年6月30日
研究完成 (实际的)
研究完成
2018年7月22日
研究注册日期
首次提交
首次提交
2017年1月5日
首先提交符合 QC 标准的
首先提交符合 QC 标准的
2017年1月6日
首次发布 (估计)
首次发布
2017年1月9日
研究记录更新
最后更新发布 (实际的)
最后更新发布
2020年3月26日
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
2020年3月25日
最后验证
最后验证
2020年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.